COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS

NCT04754698 | Completed Phase 4 DMC

• 1 other identifier: 42566621.0.0000.0068
• Study Type: interventional
• Target: 2,196
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic rheumatic diseases (such as systemic lupus erythematosus \[SLE\], rheumatoid arthritis \[RA\], ankylosing spondylitis \[AS\], juvenile idiopathic arthritis \[JIA\], poly/dermatomyositis \[PM/DM\], systemic sclerosis \[SSc\], systemic vasculitis, and primary Sjögren's syndrome \[pSS\]) are particularly susceptible to infectious diseases due to autoimmune disorder itself and its treatment (immunosuppressive therapies). Similarly, people living with HIV/AIDS (PLWHA) are predisposed to infections by different agents. The current 2019 Coronavirus Disease Pandemic-19 (COVID-19), caused by the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) began in December 2019 in Wuhan, China, and quickly became a global health and economic emergency by taking to an unprecedented burden on health systems around the world. However, SARS-Cov-2 infection raised particular concern in patients with autoimmune rheumatic diseases (DRAI) since, due to chronic inflammatory immune dysregulation and the regular use of immunosuppressive drugs, these patients are considered to be at high risk of contracting SARS-CoV-2 and potentially evolving to a worse prognosis. The overlap between the COVID-19 pandemic and the HIV/AIDS pandemic also poses an additional challenge, as the impact of co-infection is not yet fully known. The response to vaccines for other agents, however, has already been described as compromised in PLWHA. Vaccination is the most effective preventive measure to control the spread of coronavirus and to reduce associated complications. Usually, live or attenuated vaccines are not recommended for patients with chronic rheumatic diseases using immunosuppressants. However, immunization with inactivated agents is strongly indicated, resulting, in general, in good immunogenicity and adequate vaccine safety, as well as without relevant deleterious effects on diseases. Vaccine efficacy studies are needed to verify the immunogenicity of the vaccine against COVID-19 in immunosuppressed patients with rheumatological disease and those with HIV-related disease considering the risk of greater severity. In addition, it is important to assess the safety of the vaccine in this population as well as the possibility of reactivating the rheumatological disease itself. The present study will evaluate the safety and immunogenicity of the CoronaVac (Coronavirus vaccine, Sinovac Biotech Ltd.) in patients with rheumatic diseases and PLWHA

Conditions

Rheumatic Disease; HIV Infections; AIDS; Safety Issues; Immunogenicity; COVID-19

Keywords

CoronaVac; Vaccine; Rheumatic disease; Systemic lupus erythematosus; Rheumatoid arthritis; HIV; AIDS; Safety; Immunogenicity; COVID-19

Outcome Measures

Primary Outcomes (2)

• Immunogenicity 1

  Presence of ≥30% of neutralizing activity of SARS-CoV-2 antibodies

  8 months

• Immunogenicity 2

  Seroconversion rate of anti-SARS-Cov-2 IgG antibodies

  8 months

Study Arms (3)

Patients with rheumatic diseases

OTHER

CoronaVac 2-dose schedule with 21-28-day interval and a booster dose (third dose of CoronaVac) 6 months after the primary vaccination

Biological: CoronaVac

Patients with PLWHA

OTHER

CoronaVac 2-dose schedule with 21-28-day interval

Biological: CoronaVac

Healthy controls

OTHER

CoronaVac 2-dose schedule with 21-28-day interval and a booster dose (third dose of CoronaVac) 6 months after the primary vaccination

Biological: CoronaVac

Interventions

CoronaVac BIOLOGICAL

CoronaVac (Sinovac Biotech Ltd., Beijing, China)

Healthy controls; Patients with PLWHA; Patients with rheumatic diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• RA patients according to the classification criteria of the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR).
• Patients with axial spondyloarthritis (ASAS criteria 2009) and psoriatic arthritis (CASPAR 2012 criteria).
• SLE patients according to the SLICC classification criteria.
• SSc patients according to the ACR preliminary criteria.
• Patients with inflammatory myopathies according to the Bohan and Peter's criteria.
• Patients with primary vasculitis.
• Patients with pSS (2002 American-European Consensus group criteria and/or 2016 classification criteria of the EULAR/ACR.
• Patients with primary APS (primary antiphospholipid syndrome) (Sydney classification criteria).
• Patients with HIV-related illness.

You may not qualify if:

• History of anaphylactic response to vaccine components.
• Acute febrile illness.
• Guillain-Barré syndrome, decompensated heart failure (class III or IV), demyelinating disease.
• History of live virus vaccine up to 4 weeks before, virus vaccine inactivated up to 2 weeks before.
• History of having received blood products up to 6 months before the study.
• Individuals who do not accept to participate in the study and/or whose guardians do not agree to participate in the study.
• Hospitalized patients.
• Patients with severe conditions requiring hospitalization.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 05403000, Brazil

Location

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• Yuki EFN, Borba EF, Pasoto SG, Seguro LP, Lopes M, Saad CGS, Medeiros-Ribeiro AC, Silva CA, de Andrade DCO, Kupa LVK, Betancourt L, Bertoglio I, Valim J, Hoff C, Formiga FFC, Pedrosa T, Kallas EG, Aikawa NE, Bonfa E. Impact of Distinct Therapies on Antibody Response to SARS-CoV-2 Vaccine in Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2022 Apr;74(4):562-571. doi: 10.1002/acr.24824. Epub 2022 Mar 4.

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• Shinjo SK, de Souza FHC, Borges IBP, Dos Santos AM, Miossi R, Misse RG, Medeiros-Ribeiro AC, Saad CGS, Yuki EFN, Pasoto SG, Kupa LVK, Ceneviva C, Seraphim JC, Pedrosa TN, Vendramini MBG, Silva CA, Aikawa NE, Bonfa E. Systemic autoimmune myopathies: a prospective phase 4 controlled trial of an inactivated virus vaccine against SARS-CoV-2. Rheumatology (Oxford). 2022 Aug 3;61(8):3351-3361. doi: 10.1093/rheumatology/keab773.

  PMID: 34664616 DERIVED

• Medeiros-Ribeiro AC, Aikawa NE, Saad CGS, Yuki EFN, Pedrosa T, Fusco SRG, Rojo PT, Pereira RMR, Shinjo SK, Andrade DCO, Sampaio-Barros PD, Ribeiro CT, Deveza GBH, Martins VAO, Silva CA, Lopes MH, Duarte AJS, Antonangelo L, Sabino EC, Kallas EG, Pasoto SG, Bonfa E. Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial. Nat Med. 2021 Oct;27(10):1744-1751. doi: 10.1038/s41591-021-01469-5. Epub 2021 Jul 30.

  PMID: 34331051 DERIVED

MeSH Terms

Conditions

Rheumatic Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; COVID-19; Lupus Erythematosus, Systemic; Arthritis, Rheumatoid

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Respiratory Tract Diseases; Autoimmune Diseases; Arthritis; Joint Diseases

Study Officials

• Kallas, MD, PhD

  University of Sao Paulo General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study consisting of 3 arms, all of which will receive CoronaVac: patients with rheumatic diseases, PLWHA, and healthy controls. Also, in an exploratory, post hoc, substudy nested within the trial, 2 other arms will receive exercise or no intervention 1 hoour before the third dose.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 15, 2021
• Study Start: February 9, 2021
• Primary Completion: November 27, 2023
• Study Completion: March 22, 2024
• Last Updated: March 26, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)